FDA recall Z-1412-2021
Fujifilm Medical Systems U.S.A., Inc. · Class II · device
Product
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Reason for recall
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Distribution
CA, LA, MN, NC, UT, WI
Key facts
- Status
- Terminated
- Initiation date
- 2021-02-18
- Report date
- 2021-04-21
- Termination date
- 2022-02-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Lexington, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2021